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SAN DIEGO, March 5, 2021 /PRNewswire/ Cue Health Inc. (Cue) announced the healthcare technology company has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for over the counter sale of its fast, accurate, COVID-19 test, making it the nation s first molecular diagnostic test available to consumers without a prescription. The Cue COVID-19 Test for Home and Over The Counter (OTC) Use (Cue OTC Test) uses a lower nasal swab and delivers results in about 20 minutes to the user s mobile smart device. The Cue OTC Test is authorized for use by symptomatic and asymptomatic individuals, adults and children ages 2 and older with adult assistance. With an easy-to-use, fully guided experience, the Cue OTC Test offers convenience, privacy, safety, and the ability to test frequently, with the accuracy of a centralized lab test.
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SAN DIEGO, Feb. 23, 2021 /PRNewswire/ Cue Health Inc. (Cue), a healthcare technology company, today announced its molecular point-of-care COVID-19 Test has received the CE mark, clearing it for sale and distribution in the European Union (EU).
The Cue COVID-19 Test is a highly sensitive and specific nucleic acid amplification test (NAAT) that runs on the Cue Health Monitoring System, displaying test results directly on a connected mobile smart device in about 20 minutes via the Cue Health App. The Cue COVID-19 Test consists of the Cue Test Cartridge, which is a single-use, self-contained, high-sensitivity molecular assay, and the Cue Sample Wand, a lower nasal swab for minimally invasive sample collection. The reusable, battery-operated Cue Cartridge Reader runs the Cue Test Cartridge and communicates results directly to the Cue Health App. Altogether, the Cue COVID-19 Test and the Cue Health Monitoring System is a portable and connected di